- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00766051
A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU. (NBOTI)
The Efficacy of Neurophysiologically Based Occupational Therapy Intervention in the Neonatal Intensive Care Unit: An Exploratory Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy (CP) is the most common physical disability in childhood (Surveillance of Cerebral Palsy in Europe [SCPE], 2000, 2002; Winter, Autry, Boyle, & Yeargin-Allsopp, 2002),and epidemiological studies of industrialized countries indicate that CP occurs in 2.0 to 2.5 per 1000 live births (Hagberg, Hagberg, Beckung, & Uvebrant, 2001; Paneth & Kiely, 1984; Parkes, Dolk, Hill, & Pattenden, 2001). CP is defined as a movement impairment ranging from mild to severe (Bax et al., 2005; Bobath, 1954; Nelson, 2001); and occurs through social, physical and environmental causal pathways that result in a brain lesion sometime during the ante, peri or post natal period of birth (Stanley, Blair, & Alberman, 2000).
Preterm birth accounts for 40% of all cases of cerebral palsy (Stanley et al., 2000). An infant is born preterm if the birth occurs between 17-36 weeks from their date of conception. Per 1,000 births in the United States between 1989 and 1996, the rate of preterm births increased by 4%, with African American preterm births nearly twice that of whites (Morbidity and Mortality Weekly Report [MMWR], 1999). The rate of preterm birth in the United States is about 10% of all births. Early born preterm infants need organ support in neonatal intensive care unit (NICU) nurseries. Problems encountered by this population due to their undeveloped systems consist of respiratory, cardiac, central nervous system (CNS) vulnerability for damage, feeding and gastrointestinal, and kidney problems (Goldenring, 2004). Very and extremely preterm infants (less than 32 weeks) have the highest rate of developmental disability. Norm referenced cognitive, social, and neuro-developmental test scores at 6 years of age indicated that 80% of extremely preterm infants exhibited mild, moderate, and severe sensorimotor (perceptual-cognitive-motor) disability; with 12% of these infants diagnosed with disabling CP (Marlow, Wolke, Bracewell, & Samara, 2005). Rose, Feldman, & Jankowski, (2002) found that very preterm children needed 30% more time to process visual and somatosensory perceptual information needed for intellectual tasks at 5, 7, and 12 months of age. These discrepancies in efficient processing of sensorimotor stimulation continue into childhood (DeMaio-Feldman, 1994; Feder, et al. 2005) as measured from a child's cognitive responses to their environment (Barlow & Lewandowski, 2000), and internally from mechanisms that provide a foundation for equilibrium and perception such as information generated from within joints, muscles, and skin as tactile-kinesthetic information (Bracewell & Marlow,2002; de Groot, van Hoek, Hopkins, & Touwen, 1993), and as auditory, vestibular, and visual postural-spatial processing (de Graaf, Samsom, Pettersen, Schaaf, van Schie, & de Groot, 2004; De Vries, & De Groot, 2002). In addition to factors such as low birth weight that predispose infants to central nervous system insult (40%), the remaining 60% of infants who are diagnosed with CP suffer from acute insult to the CNS (hemorrhage, increased intracranial pressure, or hypoxic ischemic injury) for other reasons, such as respiratory disease, sepsis, and necrotizing enterocolitis in neonates (NEC). Many different factors, endogenous mediators and mechanisms, and mechanical, can alter vascular pressure. One respiratory condition in pre, near, and at term age infants that results in a composite of neuro-developmental and audiologic impairment (motor, cognitive, perceptual, and behavioral), ranging from between 15-50%, is persistent pulmonary hypertension in the newborn (PPHN) (Lipkin, Davidson, Rhines, & Chang, 2002; Lipkin, Davidson, Rhines, & Chang, 2002). As a respiratory disease process, PPHN can result from pulmonary hypoplasia associated with diaphragmatic, and to a lesser degree abdominal wall hernias, or from vasoconstriction associated with bacterial sepsis, in addition to other pathophysiology (Hagedorn, Gardner, Dickey, & Abman, 2006). This exploratory within group study focuses upon pre, near, and term age infants with differing diagnoses and varying degrees of risk for a diagnoses of CP, developmental coordination disorder, or sensory processing difficulties. Feeding problems are usually prevalent in infants who sustain neurological insult in addition to near term or term age infants with serious developmental disruptions. The investigators measured the intervention effects of neurophysiologically based occupational therapy upon adaptive CNS maturation using several outcome measures. Since infants in the intervention group exhibited a large treatment effect in relationship to their feeding abilities and other covariates, this study should be replicated with infants with similar diagnoses with the same longitudinal outcome measures to learn more about and to further validate the efficacy of neurophysiologically based occupational therapy upon feeding, infant sensorimotor development, and parent efficacy in the NICU.
The following collaborators assisted on this research project:
Walden University: Minneapolis, Minnesota - Ray Thron, PhD, Lela Llorens, Ph.D, OTR, FAOTA, Chester Jones, Ph.D, and Aqueil Ahmad, Ph.D
Primary Children's Medical Center: Salt Lake City, Utah - Mr. Ramsey Worman, Department of Bioengineering, David Bradley, MD and Ms. Barbara Wright, Department of Cardiology, and Mr. Doug Wolfe, Systems Administrator
Mesa State College: Grand Junction, Colorado - Richard Ott, Ph.D, Computer Science, Mathematics, & Statistics
Politecnico di Milano: P.zza Leonardo da Vinci, 32, 20133 Milano, Italy - Manuela Farrario, Ph.D, and Sergio Cerutti, Ph.D. Department of Bioingeneering
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- University of Utah / Primary Childrens Medical Center
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Salt Lake City, Utah, United States, 84132
- Univesity of Utah / Primary Childrens Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A mixed group of infants included preterm to term age infants at various levels of risk (per diagnoses) for central nervous system damage and feeding problems; but not small for dates by obstetrical dating and neurological exam, or genetic anomaly. Occupational therapy intervention began per physician approval; when patients were medically stable, and with consistent levels of blood oxygen and stable levels of supplemental oxygen (FiO2), and who were off of medication for paralysis and weaned from sedation. Historical matched control participants were matched with the intervention group participants who have the same diagnosis, gestational age, and neonatal complications.
Exclusion criteria included infants with specific cardiac distress syndrome, genetic anomalies, and small for dates.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention Group
The infants in the intervention group were problem eaters with various diagnosis
|
This study included a pre-feeding, feeding, and postural-respiratory protocol, given per the attending physician's order.
The interventions were given daily when possible, and the infants FiO2 and heart rate, along with stress behaviors, were monitored prior to, during, and after the NBOTI.
The intervention included parent education for feeding, handling, and interaction with their infant, along with nursing training during the feeding session.
The occupational therapy investigator partnered with the parents and when the parents were not available, she partnered with the nursing staff.
|
NO_INTERVENTION: Matched Historical Comparison Group
The matched historical comparison group were also problem eaters and these infants did not receive the neurophysiologically based occupational therapy Intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A Priori H1. The Number of Days to Achieve Oral Feeding Between the Intervention Group and the Matched Historical Comparison Group - From All Tube to All Oral Feeding - Was Analyzed.
Time Frame: The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).
|
This outcome measured the number of days it took to go from all tube to all oral feeding or at discharge, whichever came first.
Oral feeding percentages were based upon 150 kcal/kg/day.
Feeding volumes and weights were taken directly from the nurses notes, and averaged daily.
A two sample t-test was used to detect differences between the groups.
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The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A Priori H2: The Increase in Oral Feeding Percentage Over Days Was Correlated With Increasing Respiratory Competency During Oral Feeding; Measured as the High Frequency Percentage (HF%) of Intervention Groups' Heart Rate Variability (HRV) During Feeding.
Time Frame: The time frame was from Baseline until discharge (at or before 20 days).
|
Oral feeding percentage was based upon 150 kc/kg/day.
Heart rate data was recorded about once per week during feeding using a Holter monitor connected to the bedside ecg.
This data was downloaded in Cardiology, converted to numerical data as HRV by bioengineers at Politecnico di Milano, Italy.
As infants reached 100% of oral feedings, heart rate variability data was analyzed to determine the infants' overall trend toward relaxation, measured as increasing High Frequency Percentage (HF %).
Hierarchical linear modeling (HLM) (Singer and Willett, 2003) SPSS Grad Pack 17, mixed model analysis.
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The time frame was from Baseline until discharge (at or before 20 days).
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A Priori H3: A Total Score of the Parents' "Global Confidence" (Wolke, 1995) Was Measured on a Pre-post Test Scale.
Time Frame: Upon an infant's entry into the study, and at discharge (at or less than 20 days).
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The Global Confidence Scale of The Mother and Baby Scales (Wolke [in Brazelton and Nugent], 1995]) is a total score measure of mother/parent self efficacy in the NICU as a result of training in NBOTI.
It is a total score measure of the parent's perceived efficacy of themselves as confidence in the feeding, handling, caretaking, and interactions needed to foster relationships with their infants.
An increase in this score denotes an increase in the parent's perception of their global confidence in caring for their infant.
Global Confidence Measure uses a Likert scale.
There are three questions, ranging from -3-3.
The maximum score is 9, and the minimum score is -9.
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Upon an infant's entry into the study, and at discharge (at or less than 20 days).
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A Priori H4: A Total Scale Score of Parents' Perception of "Infant Easiness" (Wolke, 1995) Was Measured on a Pre-post Test Scale.
Time Frame: Upon an infant's entry into the study, and again at discharge (at or less than 20 days).
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The Easiness Scale measures the parent's perceived efficacy in the areas of infant irritability, sleeping habits, alertness and responsiveness, and difficulty.
The Easiness Scale(Wolke [in Brazelton and Nugent], 1995]) was used to determine mother/parent perceptions of their infants' mood and state in the NICU as a result of training in NBOTI.
An increasing score denotes an improvement in parent efficacy in their perception of their infant's easiness.uses
a Likert scale.
There are four questions, ranging from -3-3.
The maximum score is 12, and the minimum score is -12.
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Upon an infant's entry into the study, and again at discharge (at or less than 20 days).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Donald Null, Jr., M.D., University of Utah, Medical Director NCCU, Primary Children's Medical Center
- Study Director: Lynne F. La Corte, Ph.D, OTR/L, OTD, University of Utah, Division of Occupational Therapy
- Study Chair: Tracy Karp, RNC, MS, NNP, Primary Children's Hospital
Publications and helpful links
General Publications
- La Corte, L.F. (2010). The efficacy of neurophysiologically based occupational therapy intervention in the neonatal intensive care unit: An exploratory study. ProQuest/UMI Dissertation Publishing, no. 3408874. All other citations can be found in the above reference.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23739
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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